Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Colorectal Neoplasms Clinical Trial

— ADENOMA  

Official title:

Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02552017
• Other study ID #: 039/2014
• Secondary ID: 177181182104
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2015
• Last updated: September 15, 2015
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: South Tyneside NHS Foundation Trust
• Contact: Wee Sing Ngu, MBChB, MRCS
• Phone: 01914041000
• Email: wngu[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Description:

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1772
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients referred for screening, surveillance, or diagnostic colonoscopy

2. All patients must be able to give informed consent

Exclusion Criteria:

1. Patients with any absolute contraindications to colonoscopy

2. Patients with established or suspicion of large bowel obstruction or pseudo-obstruction

3. Patients with known colon cancer or polyposis syndromes

4. Patients with known colonic strictures

5. Patients with known severe diverticular segments (that is likely to impede colonoscope passage)

6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)

7. Patients lacking capacity to give informed consent

8. Pregnancy

9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.

10. Patients who are attending for a therapeutic procedure or assessment of a known lesion

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyps
• Colorectal Neoplasms

Intervention

Device:
• Endocuff Vision
Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).

Locations

Country	Name	City	State
United Kingdom	County Durham and Darlington NHS Foundation Trust	Durham	County Durham
United Kingdom	St Mark's Hospital and Academic Institute	Harrow	Middlesex
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesbrough	North Yorkshire
United Kingdom	Northumbria Healthcare NHS Foundation Trust	North Shields	Tyne and Wear
United Kingdom	South Tyneside NHS Foundation Trust	South Shields	Tyne and Wear
United Kingdom	North Tees and Hartlepool NHS Foundation Trust	Stockton-on-Tees	County Durham
United Kingdom	City Hospitals Sunderland NHS Foundation Trust	Sunderland	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
South Tyneside NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.	10 months	No
Secondary	Mean adenomas detected per procedure	A difference in mean adenomas detected per procedure between both groups	10 months	No
Secondary	Rate of cuff exchange	The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups	10 months	No
Secondary	Effect on duration of caecal intubation rates	Duration of complete withdrawal time in procedures where no polyps are detected between both groups	10 months	No
Secondary	Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires	Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).	10 months	No
Secondary	Increase in surveillance colonoscopies caused by increased adenoma detection rate	Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups	10 months	No
Secondary	Number of proximal sessile serrated polyps by histology	Number of of proximal sessile serrated polyps in both groups	10 months	No
Secondary	Polyp location	Distribution of polyps in the colon in both groups by location	10 months	No
Secondary	Adenoma detection rate of BCSP and non-BCSP endoscopists	Adenoma detection rate of BCSP and non-BCSP colonoscopists	10 months	No
Secondary	Change in adenoma detection rate of each endoscopist during the course of the trial	Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.	10 months	No
Secondary	Adenoma detection rate of individual endoscopist before and after trial commencement	Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.	10 months	No